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Medical Device Regulation

FDA-CDRH Manufacturing, Policies and Regulation Handbook

  • 1st Edition - February 22, 2023
  • Author: Elijah Wreh
  • Language: English
  • Paperback ISBN:
    9 7 8 - 0 - 3 2 3 - 9 5 3 5 4 - 2
  • eBook ISBN:
    9 7 8 - 0 - 3 2 3 - 9 5 3 5 3 - 5

Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medica… Read more

Medical Device Regulation

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Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices.